Pharmacodynamic and clinical evaluation of dose and taste-optimised low volume PEG-based bowel cleansing solutions using the split-dosing intake regimen in healthy subjects and in subjects undergoing screening colonoscopy

• Conditions: Bowel cleansing prior to colonoscopy; MedDRA version: 14.1Level: PTClassification code 10066943Term: Bowel preparationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2012-003052-37-DE
• Lead Sponsor: orgine Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-09
• Last Update Posted: 30 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) The subject’s written informed consent must be obtained prior to inclusion.
(2) Subjects age 40 to 70 years.
(3) Part B only: Subjects willing to undergo screening colonoscopy, where the subject:
(a) is between 40 and 70 years of age and has a known personal or familial risk of colon neoplasia, or
(b) is aged 55 to 70.
(4) Part A only: Subjects need to be without any history of clinically significant gastrointestinal symptoms by clinical judgement and without the presence of acute abdominal discomfort or symptoms.
(5) Females of child bearing potential must be surgically sterile, post-menopausal, practicing true sexual abstinence or using an acceptable form of effective contraception throughout the study from the following list: contraceptive injections, implants, oral contraceptives, intrauterine system (IUS), some intrauterine devices (IUDs), vasectomised partner or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository. Females using oral contraceptives must also use additional contraception. Hormonal and IUD methods of contraception must be established for a period of 3 months prior to dosing and cannot be changed or altered during the study. All females must have a negative pregnancy test at screening and check-in (unless post-menopausal).
(6) Willing, able and competent to complete the entire procedure and to comply with study instructions.
(7) Ferrous sulphate should be stopped at least one week prior to study medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

(1) Part A only: Subjects undergoing screening colonoscopy.
(2) Presence of current clinically significant functional gastrointestinal disorder (e.g. gastric emptying disorder, chronic constipation, irritable bowel syndrome [IBS]).
(3) Regular use of laxatives or colon motility altering drugs in the last month.
(4) Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of investigational drug.
(5) Any history or current presence of ileus, gastrointestinal (GI) obstruction or perforation, GI tract cancer, inflammatory bowel disease (IBD) or colonic resection.
(6) Known glucose-6-phosphatase dehydrogenase deficiency.
(7) Known phenylketonuria.
(8) History or evidence of any clinical significant cardiovascular or neurological disease, cardiac, renal or hepatic insufficiency.
(9) Known hypersensitivity to polyethylene glycols and/or ascorbic acid.
(10) History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities and/or uncontrolled hypertension.
(11) Evidence of dehydration.
(12) Any evidence for clinically significant abnormal sodium or potassium levels or other clinically significant plasma electrolyte disturbances.
(13) Females who are not post-menopausal with a positive pregnancy test. Females not using reliable methods of birth control if not post-menopausal.
(14) Clinically relevant findings on physical examination based on the Investigator’s judgement.
(15) Clinically relevant deviations of laboratory parameters from reference ranges at screening or check-in evaluation.
(16) Positive serology for chronic viral hepatitis or human immunodeficiency virus (HIV) at screening.
(17) History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or check-in evaluations.
(18) Subjects who are unwilling to comply with the provisions of the study protocol.
(19) Concurrent participation in an investigational drug study or participation within 3 months of study entry.
(20) Subject has a condition or is in a situation, which in the Investigator’s opinion may put the subject at significant risk, may confound the study results, or may interfere significantly.
(21) Previous participation in the study.
(22) Persons who are ordered to live in an institution on court or authority order.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified